WO2020104918A1 - Dispositif à taux d'administration de médicament sélectionnable - Google Patents

Dispositif à taux d'administration de médicament sélectionnable

Info

Publication number
WO2020104918A1
WO2020104918A1 PCT/IB2019/059891 IB2019059891W WO2020104918A1 WO 2020104918 A1 WO2020104918 A1 WO 2020104918A1 IB 2019059891 W IB2019059891 W IB 2019059891W WO 2020104918 A1 WO2020104918 A1 WO 2020104918A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
state
valves
valve port
port
Prior art date
Application number
PCT/IB2019/059891
Other languages
English (en)
Inventor
Charles Roger LEIGH
Original Assignee
Cochlear Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cochlear Limited filed Critical Cochlear Limited
Priority to US17/265,071 priority Critical patent/US20210244878A1/en
Publication of WO2020104918A1 publication Critical patent/WO2020104918A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3507—Communication with implanted devices, e.g. external control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves

Definitions

  • This application is directed generally to implantable systems and methods for delivery of treatment substances to a recipient.
  • Hearing loss for example, which may be due to many different causes, is generally of two types, conductive and/or sensorineural.
  • Conductive hearing loss occurs when the normal mechanical pathways of the outer and/or middle ear are impeded, for example, by damage to the ossicular chain or ear canal.
  • Sensorineural hearing loss occurs when there is damage to the inner ear, or to the nerve pathways from the inner ear to the brain.
  • auditory prostheses include, for example, acoustic hearing aids, bone conduction devices, and direct acoustic stimulators.
  • sensorineural hearing loss In many people who are profoundly deaf, however, the reason for their deafness is sensorineural hearing loss. Those suffering from some forms of sensorineural hearing loss are unable to derive suitable benefit from auditory prostheses that generate mechanical motion of the cochlea fluid. Such individuals can benefit from implantable auditory prostheses that stimulate nerve cells of the recipient's auditory system in other ways (e.g., electrical, optical and the like).
  • an apparatus which comprises a plurality of conduits and a plurality of valves in fluidic communication with the plurality of conduits.
  • the plurality of conduits is configured to receive liquid from at least one liquid reservoir configured to be implanted on or within a recipient.
  • Each conduit of the plurality of conduits has a corresponding flow resistance to the liquid.
  • the plurality of valves is configured to controllably allow flow of the liquid through a selected set of the conduits to be administered internally to the recipient with a selected flow rate.
  • a method which comprises selectively placing one or more fluid conduits of a plurality of fluid conduits in fluidic communication with at least one reservoir of a treatment liquid.
  • the at least one reservoir is configured to be implanted on or within a recipient.
  • the one or more fluid conduits are selected, at least in part, to provide a predetermined flow rate of the treatment liquid to the recipient.
  • the method further comprises implanting the at least one reservoir and the plurality of fluid conduits on or within the recipient.
  • an apparatus which comprises a housing configured to be implanted on or within a recipient.
  • the apparatus further comprises at least one reservoir and a flow control system.
  • the at least one reservoir is configured to contain a liquid.
  • the flow control system comprises at least one input port configured to receive the liquid from the at least one reservoir, and at least one output port configured to administer the liquid internally to the recipient.
  • the flow control system further comprises a plurality of flow restrictors each having a corresponding flow resistance to the liquid and a plurality of valves in fluidic communication with the plurality of flow restrictors.
  • the plurality of valves is configured to controllably allow flow from the at least one input port, through a selected set of the flow restrictors, to the at least one output port.
  • an implantable flow restrictor which comprises an inlet port, an outlet port, and a fluidic pathway that connects the inlet port to the outlet port, wherein the fluidic pathway comprises at least two conduits, and the implantable flow restrictor is configured to connect the at least two conduits in one of a plurality of configurations to set a flow resistance of the fluidic pathway.
  • a first of the at least two configurations connects at least two conduits of the at least two conduits in series.
  • a second of the at least two configurations connects at least two conduits of the at least two conduits in parallel.
  • a first conduit of the at least two conduits has a first flow resistance
  • a second conduit of the at least two conduits has a second flow resistance
  • the second flow resistance is less than two-thirds of the first flow resistance.
  • FIG. 1 is a schematic diagram illustrating the human anatomy of a recipient’s ear
  • FIG. 2A illustrates an example implantable delivery system in accordance with certain embodiments described herein;
  • FIG. 2B illustrates a first portion of the example delivery system of FIG. 2A
  • FIG. 2C is a cross-sectional view of a second portion of the example delivery system of FIG. 2A;
  • FIGs. 3A and 3B schematically illustrate two example apparatus in accordance with certain embodiments described herein;
  • FIG. 4 schematically illustrates an example apparatus having a first conduit and a second conduit in fluidic communication with a plurality of valves in accordance with certain embodiments described herein;
  • FIGs. 5A-5D schematically illustrate four states of a plurality of states in accordance with certain embodiments described herein;
  • FIGs. 6A-6D schematically illustrate a two-state first valve and a two-state second valve in accordance with certain embodiments described herein;
  • FIG. 7 schematically illustrates an example apparatus having five two-state valves in accordance with certain embodiments described herein
  • FIGs. 8A-8C schematically illustrate an example valve having three valve states in accordance with certain embodiments described herein;
  • FIGs. 8D-8F schematically illustrate another example valve having three valve states in accordance with certain embodiments described herein;
  • FIGs. 8G-8H schematically illustrate an example valve having two valve states in accordance with certain embodiments described herein;
  • FIG. 9A-9D schematically illustrates an example pair of valves having a common actuator configured to be moved linearly to change a valve state of each of the two valves in accordance with certain embodiments described herein;
  • FIG. 10 schematically illustrates an example plurality of valves comprising five valves with a common linear actuator in accordance with certain embodiments described herein;
  • FIG. 11 is a flow diagram of an example method in accordance with certain embodiments described herein.
  • Certain embodiments described herein advantageously provide an implantable drug delivery device configured to administer a liquid drug to the recipient with a selectable flow rate.
  • the device utilizes two or more flow restrictors (e.g., having different flow resistances) and a plurality of valves configured to allow liquid flow from a reservoir to the recipient by flowing through a single selected flow restrictor or multiple selected flow restrictors, in series and/or in parallel with one another, to provide a desired liquid flow rate to the recipient.
  • a recipient's ear comprises an outer ear 101, a middle ear 105, and an inner ear 107.
  • the outer ear 101 comprises an auricle 110 and an ear canal 102.
  • An acoustic pressure or sound wave 103 is collected by the auricle 110 and channeled into and through the ear canal 102.
  • a tympanic membrane 104 Disposed across the distal end of the ear canal 102 is a tympanic membrane 104 which vibrates in response to sound wave 103.
  • This vibration is coupled to the oval window or fenestra ovalis 112, which is adjacent the round window 121, through the bones of the middle ear 105.
  • the bones of the middle ear 105 comprise the malleus 108, the incus 109, and the stapes 111, collectively referred to as the ossicles 106.
  • the ossicles 106 are positioned in the middle ear cavity 113 and serve to filter and amplify the sound wave 103, causing the oval window 112 to articulate (vibrate) in response to the vibration of the tympanic membrane 104.
  • This vibration of the oval window 112 sets up waves of fluid motion of the perilymph within the cochlea 140.
  • the human skull is formed from a number of different bones that support various anatomical features. Illustrated in FIG. 1 is the temporal bone 115 which is situated at the side and base of the recipient's skull 124. For ease of reference, the temporal bone 115 is referred to herein as having a superior portion 118 and a mastoid portion 120. The superior portion 118 comprises the section of the temporal bone 115 that extends superior to the auricle 110.
  • the superior portion 118 is the section of the temporal bone 115 that forms the side surface of the skull.
  • the mastoid portion 120 referred to herein simply as the mastoid 120, is positioned inferior to the superior portion 118.
  • the mastoid 120 is the section of the temporal bone 115 that surrounds the middle ear 105.
  • semicircular canals 125 are three half-circular, interconnected tubes located adjacent the cochlea 140.
  • Vestibule 129 provides fluid communication between the semicircular canals 125 and the cochlea 140.
  • the three canals 125 are the horizontal semicircular canal 126, the posterior semicircular canal 127, and the superior semicircular canal 128.
  • the canals 126, 127, 128 are aligned approximately orthogonally to one another. Specifically, the horizontal canal 126 is aligned roughly horizontally in the head, while the superior canal 128 and the posterior canal 127 are aligned roughly at a 45 degree angle to a vertical through the center of the individual's head.
  • Each canal is filled with a fluid called endolymph and contains a motion sensor with tiny hairs (not shown) whose ends are embedded in a gelatinous structure called the cupula (also not shown).
  • the endolymph is forced into different sections of the canals.
  • the hairs detect when the endolymph passes thereby, and a signal is then sent to the brain.
  • the horizontal canal 126 detects horizontal head movements
  • the superior canal 128 and the posterior canal 127 detect vertical head movements.
  • extended treatment substance delivery refers to the delivery of treatment substances over a period of time (e.g., continuously, periodically, etc.) and can be achieved using an implantable device which controllably provides the treatment substance to the recipient.
  • the extended delivery can be activated during or after surgery and can be extended as long as is needed.
  • the period of time can immediately follow the initial implantation of the implantable device or there can be a time period between initial implantation and subsequent activation of the delivery device.
  • Certain embodiments described herein include features that facilitate controlled extended delivery of treatment substances. For example, certain embodiments are directed to apparatuses, systems, and methods for extended delivery of treatment substances in a controlled manner to deliver the treatment substances to a target location with a selected flow rate.
  • FIG. 2A illustrates an example implantable delivery system 200 in accordance with certain embodiments described herein.
  • the example delivery system 200 of FIG. 2A is sometimes referred to herein as an inner ear delivery system because it is configured to deliver treatment substances to the recipient's inner ear (e.g., the target location is the interior of the recipient's cochlea 140).
  • FIG. 2B illustrates a first portion of the example delivery system 200 of FIG. 2A
  • FIG. 2C is a cross-sectional view of a second portion of the example delivery system 200 of FIG. 2A. While FIGs.
  • FIGS. 2A-2C illustrate an example implantable delivery system 200 configured to administer at least one treatment substance to the inner ear of the recipient (e.g., to the round window 121), the implantable delivery system of certain other embodiments is configured to administer at least one treatment substance to other portions of the recipient’s body (e.g., bones; spine; organs; heart; lungs; liver; brain; stomach; pancreas; kidneys; eyes).
  • the implantable delivery system of certain other embodiments is configured to administer at least one treatment substance to other portions of the recipient’s body (e.g., bones; spine; organs; heart; lungs; liver; brain; stomach; pancreas; kidneys; eyes).
  • the example delivery system 200 of FIGs. 2A-2C comprises at least one reservoir 202, at least one valve 204, at least one delivery tube 206, and at least one delivery device 208. As shown in FIGs. 2A-2B, the example delivery system 200 includes, or is configured to be operated with, an external magnet 210. For ease of illustration, the example delivery system 200 of FIGs. 2A-2C is shown separate from any implantable auditory prostheses. However, in certain embodiments, the example delivery system 200 is configured to be used with, for example, cochlear implants, direct acoustic stimulators, bone conduction devices, etc.
  • the implantable components (e.g., reservoir 202, valve 204, delivery tube 206, etc.) of the delivery system 200 can be separate from other components of the implantable auditory prosthesis, while in certain other such embodiments, the implantable components of the delivery system 200 are integrated with the other components of the implantable auditory prosthesis.
  • the reservoir 202 is positioned within the recipient underneath a portion of the recipient's skin/muscle/fat, collectively referred to herein as tissue 219.
  • the reservoir 202 can be positioned between layers of the recipient's tissue 219 or adjacent to a subcutaneous outer surface 229 of the recipient's skull (e.g., positioned in a surgically created pocket at the outer surface 229 adjacent to a superior portion 118 of the temporal bone 115).
  • the reservoir 202 of certain embodiments is, prior to or after implantation, at least partially filled with a treatment substance for delivery to the inner ear 107 of the recipient.
  • the treatment substance can be, for example, in a liquid form, a gel form, and/or comprise nanoparticles or pellets.
  • the treatment substance can initially be in a crystalline/solid form that is subsequently dissolved.
  • the reservoir 202 can include two chambers, one that comprises a fluid (e.g., artificial perilymph or saline) and one that comprises the crystalline/solid treatment substance.
  • the fluid can be mixed with the crystalline/solid treatment substance to form a fluid or gel treatment substance that can be subsequently delivered to the recipient.
  • the reservoir 202 includes a needle port (not shown) so that the reservoir 202 can be refilled via a needle injection through the skin.
  • the reservoir 202 is explanted and replaced with another reservoir that is, prior to or after implantation, at least partially filled with a treatment substance.
  • the reservoir 202 has a preformed shape and is implanted in this shape.
  • the reservoir 202 has a first shape that facilitates implantation and a second shape for use in delivering treatment substances to the recipient.
  • the reservoir 202 can have a rolled or substantially flat initial shape that facilitates implantation, and the reservoir 202 can be configured to then expand after implantation.
  • Certain such embodiments can be used, for example, to insert the reservoir 202 through a tympanostomy into the middle ear 105 or the ear canal 102, through an opening in the inner ear 107, or to facilitate other minimally invasive insertions.
  • the reservoir 202 includes a notification mechanism (not shown) that transmits a signal or notification indicating that the reservoir 202 is substantially empty and/or needs to be refilled or replaced.
  • a notification mechanism (not shown) that transmits a signal or notification indicating that the reservoir 202 is substantially empty and/or needs to be refilled or replaced.
  • one or more electrode contacts (not shown) can be present and become electrically connected when the reservoir 202 is substantially empty.
  • Electronic components associated with or connected to the reservoir 202 can accordingly transmit a signal indicating that reservoir 202 needs to be refilled or replaced.
  • the at least one valve 204 is positioned between the at least one reservoir 202 and the at least one delivery tube 206, is in fluidic communication with the at least one reservoir 202 and the at least one delivery tube 206, and is configured to control flow of the treatment substance from the at least one reservoir 202 to the recipient via the at least one delivery tube 206.
  • the at least one valve 204 comprises a check valve (e.g., one-way valve) configured to allow the treatment substance to pass through the check valve in one direction only so that the released treatment substances do not back- flow into the reservoir 202.
  • the at least one valve 204 comprises a valve that is configured to open in response to the pressure change in the reservoir 202 (e.g., ball check valve, diaphragm check valve, swing check valve, tilting disc check valve, etc.).
  • the at least one valve 204 comprises a stop-check valve that can be controllably opened or closed (e.g., by an external mechanism; by a controller of an implanted portion of the delivery system 200) to control the flow regardless of forward pressure.
  • the stop-check value can be controlled by an external electric or magnetic field generated by the external magnet 210, an electromagnet, etc.
  • variable strengths of the magnetic field are used to control the valve 204 and therefore the dosage of the treatment substance.
  • the stop-check valve of certain embodiments includes an override control to stop flow regardless of flow direction or pressure, as well as closing in response to backflow or insufficient forward pressure (e.g., as in a normal check valve).
  • the stop-check valve is configured to prevent unintended dosing of the treatment substance when, for example, an accidental external force acts on the reservoir 202.
  • the reservoir 202 is formed such that an increase in pressure of the reservoir 202 without an accompanying treatment substance release will not damage (e.g., rupture) the reservoir 202.
  • a magnetically activated stop-check valve is merely exemplary and other types of valves can be used in accordance with certain embodiments described herein.
  • the at least one valve 204 can be actuated (e.g., opened) in response to an electrical signal (e.g., piezoelectric valve).
  • the electrical signal is received from a portion of an auditory prosthesis (not shown) that is implanted with the delivery system 200 or the electrical signal is received from an external device (e.g., an RF actuation signal received from an external sound processor, remote control, etc.).
  • the at least one valve 204 is actuated manually (e.g., by a force applied by a finger).
  • the delivery tube 206 includes a proximal end 212 and a distal end 214.
  • the proximal end 212 of the delivery tube 206 is in fluidic communication with the at least one valve 204 through which the treatment substance is controllably released from the reservoir 202.
  • the distal end 214 of the delivery tube 206 comprises a delivery device 208 which, in certain embodiments, is disposed within the distal end 214 of the delivery tube 206, positioned abutting the round window 121, and configured to be in fluidic communication with the recipient's round window 121.
  • the delivery tube 206 can be secured within the recipient so that the distal end 214 remains located adjacent to the round window 121.
  • the delivery device 208 e.g., wick, sponge, permeating gel, hydrogel; non-return valve
  • the delivery device 208 is configured to operate as a transfer mechanism to transfer the treatment substance from the delivery tube 206 to the recipient.
  • the delivery device 208 can be in fluidic communication with the round window 121 such that once the treatment substance is released through the valve 204, the treatment substance flows through the delivery tube 206 to the delivery device 208, and enters the cochlea 140 through the round window 121 (e.g., via osmosis).
  • the example delivery system 200 comprises an active actuation mechanism (e.g., a pump) configured to transfer the at least one treatment substance from the at least one reservoir 202 to the recipient via the at least one delivery device 208 at the distal end 214 of the at least one delivery tube 206.
  • an active actuation mechanism e.g., a pump
  • the example delivery system 200 can comprise a mechanism (e.g., at least one spring) configured to controllably apply a force to at least one compressible part or portion of the reservoir 202 (e.g., a wall 220 or a portion thereof, formed from a resiliently flexible material) so as to propel (e.g., push) a portion of the treatment substance out of the reservoir 202 through the valve 204 (e.g., via peristaltic pumping).
  • a mechanism e.g., at least one spring
  • the delivery system 200 provides an alternative ability of controlling the flow rate.
  • the actuation mechanism is self- actuating (e.g., without external control) and the delivery system 200 provides the sole ability of controlling the flow rate.
  • the delivery system 200 provides the sole ability of controlling the flow rate.
  • a phase material change e.g., two chambers separated by a deformable membrane within the implant body, one chamber with a phase change material and the other chamber containing the treatment material
  • the example delivery system 200 utilize a passive actuation mechanism configured to transfer the at least one treatment substance from the at least one reservoir 202 to the recipient via the at least one delivery device 208 at the distal end 214 of the at least one delivery tube 206.
  • the reservoir 202 can be positioned adjacent to the outer surface 229 of the recipient’s skull so that an external force 216 can be applied to a compressible part or portion of the reservoir 202 (e.g., a wall 220 or a portion thereof, formed from a resiliently flexible material) which can be configured to deform in response to application of the external force 216 to propel (e.g., push) the treatment substance from the reservoir 202.
  • the positioning of the reservoir 202 adjacent to the superior portion 118 of the mastoid 115 provides a rigid surface that counters the external force 216.
  • a pressure change occurs in the reservoir 202 so as to propel (e.g., push) a portion of the treatment substance out of the reservoir 202 through the valve 204.
  • FIG. 2B illustrates an example arrangement in which the reservoir 202 includes a resiliently flexible wall 220, which can be formed from various resiliently flexible parts and rigid parts and which can have a variety of shapes and sizes (e.g., cylindrical, square, rectangular, etc.) or other configurations.
  • the reservoir 202 can further include a spring-mounted base that maintains a pressure in the reservoir 202 until the reservoir 202 is substantially empty.
  • Other mechanisms for maintaining a pressure in the reservoir can be used in other arrangements.
  • the external force 216 is applied manually using, for example, a user's finger.
  • the user can press on the tissue 219 adjacent to the reservoir 202 to create the external force 216.
  • a single finger press is sufficient to propel the treatment substance through valve 204.
  • multiple finger presses are used to create a pumping action that propels the treatment substance from the reservoir 202.
  • the external force 216 is applied through a semi-manual method that uses an external actuator 217, as shown in FIG. 2B.
  • the external actuator 217 can be pressed onto the soft tissue 219 under which the reservoir 202 is located. The movement (e.g., oscillation/vibration) of the actuator 217 deforms the reservoir 202 to create the pumping action that propels the treatment substance out of the reservoir 202.
  • the force applied to the reservoir 202 to propel the treatment substance from the reservoir 202 is generated by a recipient's muscle (e.g., temporalis, temporal muscle, jaw, etc.) and hard tissue (e.g., bone, teeth, etc.).
  • the muscle (not shown) can be in a relaxed state where little or no pressure is placed on the reservoir 202 or alternatively can be in a contracted state that compresses the reservoir 202.
  • the compression of the reservoir 202 in response to the muscle contraction propels the treatment substance from the reservoir 202 into the delivery tube 206 via the valve 204.
  • the muscle can be contracted through mastication.
  • the reservoir 202 can include a magnetic positioning member 213 located at or near an optimal location for application of an external force from the actuator 217.
  • the actuator 217 can include a magnet 215 configured to magnetically mate with the magnetic positioning member 213. As such, when the actuator 217 is properly positioned, the magnet 215 mates with the magnetic positioning member 213 and the force from the actuator 217 is applied at the optimal location.
  • the example delivery system 200 comprises a controller (e.g., implanted electronics 253, shown using dotted lines in FIG. 2B) configured to be in communication with an actuator (e.g., active or passive actuation mechanism) and/or the valve 204.
  • the implanted electronics 253 can be configured to control the actuation mechanism and/or the valve 204 to control the release of the treatment substance from the reservoir 202 to the recipient.
  • the implanted electronics 253 is powered and/or controlled through a transcutaneous link (e.g., RF link).
  • the implanted electronics 253 can include or be electrically connected to an RF coil, receiver/transceiver unit, etc.
  • the implanted electronics 253 includes or is connected to at least one sensor that is configured, at least in part, to assist in control of delivery of the treatment substance to the recipient.
  • the at least one sensor e.g., a temperature sensor, a sensor to detect infection or bacteria growth, etc.
  • the at least one sensor can provide indications of conditions under which delivery of the treatment substance is to occur (e.g., for a period of time) and/or conditions under which delivery of the treatment substance is to be ceased (e.g., for a period of time).
  • the at least one sensor can also be configured to determine an impact of the treatment substance on the recipient (e.g., evaluate effectiveness of the treatment substance).
  • FIGs. 3A and 3B schematically illustrate two example apparatus 300 in accordance with certain embodiments described herein.
  • the apparatus 300 comprises a plurality of conduits 310 configured to receive liquid 320 from at least one liquid reservoir 202 (not shown in FIGs. 3A and 3B) configured to be implanted on or within a recipient.
  • Each conduit 310 of the plurality of conduits 310 has a corresponding flow resistance to the liquid 320.
  • the apparatus 300 further comprises a plurality of valves 330 in fluidic communication with the plurality of conduits 310.
  • the plurality of valves 330 is configured to controllably allow flow of the liquid 320 through a selected set of the conduits 310 to be administered internally to the recipient with a selected flow rate.
  • the selected set can comprise a single selected conduit 310 of the plurality of conduits 310 or can comprise multiple selected conduits 310 of the plurality of conduits 310, with two or more of the selected conduits 310 in series with one another and/or with two or more of the selected conduits 310 in parallel with one another.
  • the plurality of conduits 310 of certain embodiments comprises two conduits 310, a first conduit 310a and a second conduit 310b.
  • Other numbers of conduits 310 e.g., 2, 3, 4, 5, or more
  • the conduits 310 of certain embodiments comprise tubular structures (e.g., capillary tubing of plastic, rubber, and/or metal such as steel), such as have been used in implantable infusion pumps, each having an inlet portion and an outlet portion.
  • conduits 310 can comprise a spiral-shaped flow restrictor, having its inlet portion in fluidic communication with the plurality of valves 330 and its outlet portion in fluidic communication with the plurality of valves 330.
  • conduits 310 include, but are not limited to, grooves or channels etched into a structure (e.g., plate; glass; silica chip), fluid pathways formed in a molded or vapor deposited component (e.g., silicone; parylene), needle restrictors, channel restrictors, orifice plate restrictors, and other flow restrictors that have been used in implantable infusion pumps.
  • the flow resistance of each conduit 310 is different from the flow resistance of each of the other conduits 310, while in certain other embodiments, the flow resistances of two or more of the conduits 310 are equal to one another.
  • the flow resistance of a conduit 310 is dependent at least in part upon structural characteristics of the conduit 310.
  • the first conduit 310a has a first flow resistance dependent at least in part upon structural characteristics of the first conduit 310a
  • the second conduit 310b has a second flow resistance dependent at least in part upon structural characteristics of the second conduit 310b, with the second flow resistance lower than the first flow resistance.
  • the flow resistance of a conduit 310 can be expressed as the pressure difference of the liquid 320 between the inlet portion and the outlet portion divided by the flow rate of the liquid 320 through the conduit 310.
  • the flow resistance R of an example conduit 310 having an inner passageway with a uniform circular cross-section can be expressed as:
  • the lengths L of the conduits 310 can range from 15 cm to 30 m and the inner dimensions (e.g., radii; diameters; widths) of the passageways (e.g., having circular, square, rectangular, or other geometric or non-geometrical cross-sectional shapes) of the conduits 310 can range from 5 pm to 50 pm.
  • the inner dimensions of the passageway of the conduit 310 in certain embodiments is generally uniform along the length of the conduit 310, while in certain other embodiments, the inner dimensions are non-uniform along the length of the conduit 310.
  • FIG. 3 A schematically illustrates the first conduit 310a and the second conduit 310b having different lengths L, with the first conduit 310a longer than the second conduit 310b and the first flow resistance higher than the second flow resistance.
  • FIG. 3B schematically illustrates the first conduit 310a and the second conduit 310b having different inner dimensions (e.g., inner radii r), with the passageway of the first conduit 310a narrower than the passageway of the second conduit 310b and the first flow resistance higher than the second flow resistance.
  • the conduits 310 have both differing lengths and differing inner dimensions such that the flow resistances of the conduits 310 differ from one another.
  • the liquid 320 comprises one or more treatment substances (e.g., medicines; drugs; pharmaceutical compositions; genetic materials having a direct or indirect genetic therapeutic effect; biologic substances that comprise living matter or are derived from living matter intended to have a therapeutic effect; antispasmodics; anti inflammatories; anti-cancer or chemotherapeutic agents; analgesic pain control medications; insulin; steroids) which can be, for example, in a liquid form, a gel form, and/or comprise nanoparticles or pellets.
  • treatment substances e.g., medicines; drugs; pharmaceutical compositions; genetic materials having a direct or indirect genetic therapeutic effect; biologic substances that comprise living matter or are derived from living matter intended to have a therapeutic effect; antispasmodics; anti inflammatories; anti-cancer or chemotherapeutic agents; analgesic pain control medications; insulin; steroids
  • the liquid 320 comprises a solvent or carrier liquid (e.g., water; saline; artificial perilymph) in which the treatment substance is dissolved, suspended, or mixed (e.g., prior to placing the liquid 320 within the reservoir 202 or immediately prior to flowing the liquid 320 through the plurality of valves 330) and subsequently delivered to the recipient.
  • a solvent or carrier liquid e.g., water; saline; artificial perilymph
  • FIG. 4 schematically illustrates an example apparatus 300 having a first conduit 310a and a second conduit 310b in fluidic communication with a plurality of valves 330 in accordance with certain embodiments described herein.
  • the plurality of valves 330 comprises a first port 332a in fluidic communication with an inlet portion of the first conduit 310a, a second port 332b in fluidic communication with an outlet portion of the first conduit 310a, a third port 332c in fluidic communication with an inlet portion of the second conduit 310b, and a fourth port 332d in fluidic communication with an outlet portion of the second conduit 310b.
  • the plurality of valves 330 further comprises an inlet port 334 in fluidic communication with an inlet conduit 340 which is in fluidic communication with at least one reservoir 202 (not shown in FIG. 4) and an outlet port 336 in fluidic communication with an outlet conduit 350 (e.g., a delivery tube 206) in fluidic communication with a target region of the recipient at which the liquid 320 comprising the treatment substance is to be administered.
  • an outlet conduit 350 e.g., a delivery tube 206
  • the plurality of valves 300 is configured to be placed in a selected state of a plurality of states.
  • FIGs. 5A-5D schematically illustrate four states of a plurality of states in accordance with certain embodiments described herein.
  • a first state schematically illustrated by FIG. 5A
  • the plurality of valves 300 allows flow of the liquid 320 through the first conduit 310a and the second conduit 310b in series with one another.
  • a second state schematically illustrated by FIG. 5B
  • the plurality of valves 300 allows flow of the liquid 320 through the first conduit 310a and does not allow flow of the liquid 320 through the second conduit 310b.
  • a third state schematically illustrated by FIG.
  • the plurality of valves 300 allows flow of the liquid 320 through the second conduit 310b and does not allow flow of the liquid 320 through the first conduit 310a.
  • a fourth state schematically illustrated by FIG. 5D, the plurality of valves 300 allows flow of the liquid through the first conduit 310a and the second conduit 310b in parallel with one another.
  • the plurality of states comprises a fifth state in which the plurality of valves 330 does not allow flow of the liquid 320 through either the first conduit 310a or the second conduit 310b.
  • the liquid 320 flows through the apparatus 300 (e.g., from the inlet conduit 340, through the outlet conduit 350, to the recipient) with a flow rate Q that is dependent on the state of the plurality of valves 330.
  • the first flow resistance Ri of the first conduit 310a is higher than the second flow resistance R2 of the second conduit 310b (R / > R2), so for the same pressure differential AP between the inlet port 334 and the outlet port 336, the flow rates Qi, Q2, Q3, and Q4 of the apparatus 300 with the plurality of valves 300 in the first state, second state, third state, and fourth state, respectively, have the following relationship: Q 4 > Q 3 > Q 2 > Qi-
  • each of the conduits 310 is configured to have a corresponding flow resistance such that the flow rates for the states of the plurality of valves 330 are differentiated from one another.
  • the apparatus 300 is configured to be provided to a medical professional (e.g., surgeon) with each of the valves of the plurality of valves 330 in a predetermined state (e.g., in a“factory configuration” which has a predetermined“factory” flow rate), and the medical professional can select a desired configuration of the apparatus 300 by selecting and actuating none, one, or more of the valves such that the apparatus 300 is set to provide a selected flow rate (e.g., the same as the“factory” flow rate or different from the “factory” flow rate).
  • the apparatus 300 is configured to provide a default minimum flow rate (e.g., greater than zero) when in a configuration in which all of the valves of the plurality of valves 330 are in“closed” states.
  • the plurality of valves 330 comprises one or more check valves, stop-check valves, or other types of valves.
  • some or all of the valves of the plurality of valves 330 are configured to be switched multiple times (e.g., reversibly switchable; multiple actuations) between valve states of the valve.
  • at least one valve can be configured to be switched to a second valve state from an initial first valve state, and configured to be subsequently switched back to the first valve state or to another valve state different from the second valve state.
  • valves of the plurality of valves 330 are configured to be switched once (e.g., irreversibly switchable; single actuation) between valve states of the valve.
  • at least one valve can be configured to be switched to a second valve state from an initial first valve state, and configured to not be subsequently switched back to the first valve state or to another valve state different from the second valve state.
  • valves that are configured to be switched once include, but are not limited to, at least one conduit section configured to be irreversibly compressed (e.g., collapsed; crushed) such that liquid flow through the at least one conduit section is prevented.
  • the conduit section of certain such embodiments is plastically deformable or malleable by localized pressure applied to a wall of the conduit section.
  • the conduit section of certain other such embodiments is resilient and the valve further comprises a plastically deformable or malleable actuator (e.g., plate) configured to be pressed against a wall of the conduit section, causing the actuator to be irreversibly deformed into a configuration which compresses (e.g., collapses; crushes) the conduit section such that liquid flow through the conduit section is prevented.
  • a plastically deformable or malleable actuator e.g., plate
  • the apparatus 300 is configured to be provided to a medical professional (e.g., surgeon) with each of one or more irreversibly switchable valves of the plurality of valves 330 in an“open” state (e.g., such that the apparatus 300 provides the “factory” flow rate), and the medical professional can select a desired configuration of the apparatus 300 by selecting and actuating (e.g., irreversibly closing) none, one, or more of the one or more irreversibly switchable valves such that the apparatus 300 is set to provide a selected flow rate (e.g., the same as the“factory” flow rate or different from the“factory” flow rate).
  • a medical professional e.g., surgeon
  • each of one or more irreversibly switchable valves of the plurality of valves 330 in an“open” state e.g., such that the apparatus 300 provides the “factory” flow rate
  • the medical professional can select a desired configuration of the apparatus 300 by selecting and actuating (e.g., irreversibly closing) none,
  • valves of the plurality of valves 330 are configured to be manually switched (e.g., by a medical professional manipulating a button or other mechanism mechanically coupled to the actuator of the valve) between the valve states of the valve prior to or during implantation of the apparatus 300 on or within a recipient.
  • some or all of the valves of the plurality of valves 330 are configured to be switched (e.g., by an electromechanical mechanism or motor mechanically coupled to the actuator of the valve) between the valve states of the valve subsequently to implantation of the apparatus 300 (e.g., in response to commands received from a controller circuitry internal or external to the apparatus 300 being used by a medical professional).
  • valves compatible with certain embodiments described herein include but are not limited to, the at least one valve 204 and accompanying mechanisms as described herein with regard to FIGs. 2A and 2B.
  • the plurality of valves 330 comprises at least one valve having an actuator configured to be moved to change the valve between an open state and a closed state (e.g., referred to herein as a“two-state valve”).
  • the two-state valve can comprise a rotatable actuator mechanically coupled to a valve conduit such that the valve conduit is in fluidic communication with both an inlet valve port and an outlet valve port when the actuator is in a first orientation (e.g., an open orientation) and the valve conduit is not in fluidic communication with one or both of the inlet valve port or the outlet valve port when the actuator is in a second orientation (e.g., a closed orientation) that differs from the first orientation (e.g., by 90 degrees).
  • a first orientation e.g., an open orientation
  • a second orientation e.g., a closed orientation
  • the two-state valve can comprise a linearly movable actuator mechanically coupled to a mechanism (e.g., disc and seat; moveable conduit) configured to be switched between a first position (e.g., an open position) in which the mechanism allows liquid flow from the inlet valve port to the outlet valve port and a second position (e.g., a closed position) in which the mechanism prevents liquid flow from the inlet valve port to the outlet valve port.
  • a mechanism e.g., disc and seat; moveable conduit
  • FIGs. 6A-6D schematically illustrate a two-state first valve 330a and a two- state second valve 330b in accordance with certain embodiments described herein. While FIGs. 6A-6D illustrate the first valve 330a and the second valve 330b as each comprising a rotatable actuator 360a, b mechanically coupled to a valve conduit 362a, b, other types of two- state valves (e.g., linearly actuated valves) are also compatible with certain embodiments described herein.
  • other types of two- state valves e.g., linearly actuated valves
  • the first valve 330a is configured to be controllably opened and closed to selectively place the inlet port 334 in fluidic communication with the first port 332a (and the inlet portion of the first conduit 310a), and the second valve 330b is configured to be controllably opened and closed to selectively place the inlet port 334 in fluidic communication with the third port 332c (and the inlet portion of the second conduit 310b).
  • the first valve 330a is open and the inlet port 334 is in fluidic communication with the first port 332a, and the second valve 330b is closed and the inlet port 334 is not in fluidic communication with the third port 332c.
  • This configuration of the first valve 330a and the second valve 330b is compatible with the first state of the plurality of valves 330 schematically illustrated by FIG. 5A and with the second state of the plurality of valves 330 schematically illustrated by FIG. 5B.
  • FIG. 5A the first state of the plurality of valves 330 schematically illustrated by FIG. 5A
  • FIG. 5B As schematically illustrated by FIG.
  • the first valve 330a is closed and the inlet port 334 is not in fluidic communication with the first port 332a, and the second valve 330b is open and the inlet port 334 is in fluidic communication with the third port 332c.
  • This configuration of the first valve 330a and the second valve 330b is compatible with the third state of the plurality of valves 330 schematically illustrated by FIG. 5C.
  • the first valve 330a is open and the inlet port 334 is in fluidic communication with the first port 332a
  • the second valve 330b is open and the inlet port 334 is in fluidic communication with the third port 332c.
  • This configuration of the first valve 330a and the second valve 330b is compatible with the fourth state of the plurality of valves 330 schematically illustrated by FIG. 5D.
  • the first valve 330a is closed and the inlet port 334 is not in fluidic communication with the first port 332a
  • the second valve 330b is closed and the inlet port 334 is not in fluidic communication with the third port 332c.
  • This configuration of the first valve 330a and the second valve 330b is compatible with a fifth state of the plurality of valves 330 in which the liquid 320 does not flow through either the first conduit 310a or the second conduit 310b.
  • FIG. 7 schematically illustrates an example apparatus 300 having five two- state valves in accordance with certain embodiments described herein.
  • the first valve 330a (labeled“A”) and the second valve 330b (labeled“B”) are configured as described herein with regard to FIGs. 6A-6D.
  • a third valve 330c (labeled“C”) is configured to be controllably opened and closed to selectively place the second port 332b in fluidic communication with the outlet port 336.
  • a fourth valve 330d (labeled“D”) is configured to be controllably opened and closed to selectively place the second port 332b in fluidic communication with the third port 332c (and the inlet portion of the second conduit 310b).
  • a fifth valve 330e (labeled“E”) that is configured to be controllably opened and closed to selectively place the fourth port 332d in fluidic communication with the outlet port 336.
  • the apparatus 300 does not include a fifth valve 330e.
  • Table 1 provides the states of each of the five two-state valves 330a-e corresponding to the plurality of states schematically illustrated in FIGs. 5A-5D in accordance with certain embodiments described herein.
  • the fifth state of no fluid flow can be achieved by closing the first valve 330a and the second valve 330b (e.g., preventing the liquid 320 from entering the plurality of valves 330)
  • the fifth state can be achieved by instead closing the third valve 330c and the fifth valve 330e (e.g., preventing the liquid 320 from leaving the plurality of valves 330).
  • the fifth valve (“Valve E”) is not included.
  • the slow fluid flow state e.g., as shown in FIG.
  • Valve E can be achieved with Valve E in an“open” state, or without Valve E entirely (e.g., an apparatus 300 having four two-state valves).
  • Valve E can be a check valve (e.g., a valve that permits flow in one direction from the port 332d to the outlet port 336) that prevents back flow without requiring actuation (e.g., manual or otherwise).
  • FIGs. 8A-8C schematically illustrate an example valve 330f having three valve states in accordance with certain embodiments described herein.
  • FIGs. 8D-8F schematically illustrate another example valve 330g having three valve states in accordance with certain embodiments described herein.
  • FIGs. 8G-8H schematically illustrate an example valve 330h having two valve states in accordance with certain embodiments described herein.
  • Both of the valves 330f,g are referred to herein as a“three-state valve,” and the valve 330h is referred to herein as a two-state valve.
  • the valves 330f-h are schematically illustrated in FIGs. 8A-8H as having rotatable actuators, other types of three-state valves and two-state valves (e.g., utilizing linear motion actuators) are also compatible with certain embodiments described herein.
  • the valve 330f of FIGs. 8A-8C has a first valve port (e.g., in fluidic communication with the inlet port 334), a second valve port (e.g., in fluidic communication with the first port 332a), and a third valve port (e.g., in fluidic communication with the third port 332c).
  • the valve 330f is configured to be placed in a selected valve state of a plurality of valve states. In a first valve state of the valve 330f, the first valve port is in fluidic communication with the second valve port and with the third valve port (e.g., such that the inlet port 334 is in fluidic communication with both the first port 332a and the third port 332c).
  • the first valve port is in fluidic communication with the second valve port and is not in fluidic communication with the third valve port (e.g., such that the inlet port 334 is not in fluidic communication with the first port 332a and is in fluidic communication with the third port 332c).
  • the first valve port is not in fluidic communication with the second valve port and is in fluidic communication with the third valve port (e.g., such that the inlet port 334 is in fluidic communication with the first port 332a and is not in fluidic communication with the third port 332c).
  • the valve 330g of FIGs. 8D-8F has a first valve port (e.g., in fluidic communication with the second port 332b), a second valve port (e.g., in fluidic communication with the outlet port 336), and a third valve port (e.g., in fluidic communication with the third port 332c).
  • the valve 330g is configured to be placed in a selected valve state of a plurality of valve states. In a first valve state of the valve 330g, the first valve port is in fluidic communication with the second valve port and is not in fluidic communication with the third valve port (e.g., such that the second port 332b is in fluidic communication with the outlet port 336 and is not in fluidic communication with the third port 332c).
  • the first valve port is not in fluidic communication with either the second valve port or the third valve port, and the second valve port is not in fluidic communication with the third valve port (e.g., such that the second port 332b is not in fluidic communication with either the outlet port 336 or the third port 332c and the outlet port 336 is not in fluidic communication with the third port 332c).
  • the first valve port is in fluidic communication with the third valve port and is not in fluidic communication with the second valve port (e.g., such that the second port 332b is in fluidic communication with the third port 332c and is not in fluidic communication with the outlet port 336).
  • the valve 330h of FIGs. 8G-8H (a two-state valve) has a first valve port (e.g., in fluidic communication with the fourth port 332d) and a second valve port (e.g., in fluidic communication with the outlet port 336).
  • the valve 330h is configured to be placed in a selected valve state of a plurality of valve states. In a first valve state of the valve 330h, the first valve port is in fluidic communication with the second valve port (e.g., such that the fourth port 332d is in fluidic communication with the outlet port 336).
  • the first valve port is not in fluidic communication with the second valve port (e.g., such that the fourth port 332d is not in fluidic communication with outlet port 336).
  • the valve 330h is not included.
  • the slow fluid flow state e.g., as shown in FIG. 5B
  • the valve 330h in an“open” state can be achieved with the valve 330h in an“open” state, or without the valve 330h entirely (e.g., an apparatus 300 having only the two three-state valves 330f,g).
  • valve 8A-8C is used in place of the two two-state valves 330a, b (labeled A and B) of FIG. 7 and/or the three-state valve 330g is used in place of the two two-state valves 330c, d (labeled C and D) of FIG. 7.
  • Other valves with different numbers of valve states and other configurations of the plurality of valves 300 are also compatible with certain embodiments described herein.
  • FIG. 9A-9D schematically illustrates an example pair of valves 330i,j having a common actuator 380 configured to be moved linearly to change a valve state of each of the two valves 330i,j in accordance with certain embodiments described herein.
  • the actuator 380 of FIGs. 9A-9D comprises an elongate member 382 configured to be moved linearly within a valve body 390 having four valve ports 392a,b,c,d.
  • the elongate member 382 comprises at least one recess 384 (e.g., hole; narrow portion) configured to allow liquid flow across or through the elongate member 380.
  • recess 384 e.g., hole; narrow portion
  • the at least one recess 384 comprises a first recess 384a and a second recess 384b spaced apart from one another along the elongate member 382.
  • the elongate member 382 further comprises at least one portion 386 configured to prevent liquid flow across or through the elongate member 382.
  • FIG. 9A schematically illustrates a first valve state in which the elongate member 382 is positioned such that the valve 330i is open (e.g., the two valve ports 392a, b are in fluidic communication with one another via the recess 384a), and the valve 330j is closed (e.g., the two valve ports 392c, d are not in fluidic communication with one another).
  • FIG. 9A schematically illustrates a first valve state in which the elongate member 382 is positioned such that the valve 330i is open (e.g., the two valve ports 392a, b are in fluidic communication with one another via the recess 384a), and the valve 330j is closed (e.g., the two valve ports 392c, d are not in fluidic communication with one another).
  • FIG. 9A schematically illustrates a first valve state in which the elongate member 382 is positioned such that the valve 330i is open (e.g., the two valve ports 3
  • FIG. 9B schematically illustrates a second valve state in which the elongate member 382 is positioned such that the valve 330i is open (e.g., the two valve ports 392a, b are in fluidic communication with one another via the recess 384b) and the valve 330j is open (e.g., the two valve ports 392c, d are in fluidic communication with one another via the recess 382a).
  • FIG. 9C schematically illustrates a third valve state in which the elongate member 382 is positioned such that the valve 330i is closed (e.g., the two valve ports 392a, b are not in fluidic communication with one another) and the valve 330j is closed (e.g., the two valve ports 392c, d are not in fluidic communication with one another).
  • FIG. 9C schematically illustrates a third valve state in which the elongate member 382 is positioned such that the valve 330i is closed (e.g., the two valve ports 392a, b are not in fluidic communication with one another) and the valve 330j is closed (e.g., the two valve ports 392c, d are not in fluidic communication with one another).
  • FIG. 9D schematically illustrates a fourth valve state in which the elongate member 382 is positioned such that the valve 330i is closed (e.g., the two valve ports 392a, b are not in fluidic communication with one another) and the valve 330j is open (e.g., the two valve ports 392c, d are in fluidic communication with one another via the recess 384b).
  • a pair of valves 330i,j as schematically illustrated by FIGs. 9A-9D are used in place of the two valves 330a, b (labeled A and B) of FIG. 7 and/or in place of the two valves 330c, d (labeled C and D) of FIG. 7.
  • FIG. 10 schematically illustrates an example plurality of valves 330 comprising five valves with a common linear actuator 380 in accordance with certain embodiments described herein.
  • the elongate member 382 comprises a plurality of recesses 384 and a plurality of portions 386 arranged along the elongate member 382 such that the state of the plurality of valves 330 is set by linearly translating the elongate member 382 to align the recesses 384 and portions 386 appropriately with the ports of the plurality of valves 330.
  • the elongate member 382 For a first flow rate (e.g., the fastest flow rate), the elongate member 382 is positioned such that the plurality of valves 330 allows flow of the liquid 320 through the first conduit 310a and the second conduit 310b in parallel with one another. For a second flow rate (e.g., the fast flow rate), the elongate member 382 is positioned such that the plurality of valves 330 allows flow of the liquid 320 through the second conduit 310b but not the first conduit 310a. For a third flow rate (e.g., the slow flow rate), the elongate member 382 is positioned such that the plurality of valves 330 allows flow of the liquid 320 through the first conduit 310a but not the second conduit 310b.
  • a first flow rate e.g., the fastest flow rate
  • the elongate member 382 For a second flow rate (e.g., the fast flow rate), the elongate member 382 is positioned such that the pluralit
  • the elongate member 382 is positioned such that the plurality of valves 330 allows flow of the liquid 320 through the first conduit 310a and the second conduit 310b in series with one another.
  • the sections of the elongate member 382 corresponding to the different flow rates can be arranged such that the state of the plurality of valves 330 can be changed by moving the elongate member 382 by discrete steps along an axial direction of the elongate member 382, the discrete steps equal to the spacings between the adjacent recesses 384 and portions 386.
  • switching to the second state can be achieved by moving the elongate member 382 by 2 discrete steps
  • switching to the first state e.g., the“slowest” flow rate
  • switching to the fourth state e.g., the“fastest” flow rate
  • FIG. 11 is a flow diagram of an example method 400 in accordance with certain embodiments described herein.
  • the method 400 comprises selectively placing one or more fluid conduits of a plurality of fluid conduits (e.g., a plurality of conduits 310; a plurality of flow restrictors) in fluidic communication with at least one reservoir of a treatment liquid (e.g., a reservoir 202 containing a liquid 420 comprising at least one treatment substance).
  • the at least one reservoir is configured to be implanted on or within a recipient.
  • the one or more fluid conduits are selected, at least in part, to provide a predetermined flow rate of the treatment liquid to the recipient.
  • the method 400 further comprises implanting the at least one reservoir and the plurality of fluid conduits on or within the recipient.
  • the method 400 further comprises allowing the treatment liquid to flow from the at least one reservoir through the selected one or more fluid conduits to administer the treatment liquid to the recipient.
  • the at least one reservoir and the plurality of fluid conduits are contained within a housing configured to be implanted on or within the recipient.
  • the housing can be formed of a biocompatible material (e.g., silicone; thermoplastic polymer resin, thermoplastic elastomer; platinum; platinum alloy; titanium; titanium alloy) and the housing can hermetically seal an inner region of the housing from an outer environment of the housing.
  • the housing also contains a flow control system in fluidic communication with the at least one reservoir and the plurality of fluid conduits.
  • the flow control system can comprise at least one input port (e.g., inlet conduit 340 and inlet port 334) configured to receive the treatment liquid from the at least one reservoir, and at least one output port (e.g., outlet port 336 and outlet conduit 350) configured to administer the treatment liquid internally to the recipient.
  • the flow control system of certain embodiments further comprises a plurality of valves (e.g., a plurality of valves 330) in fluidic communication with the plurality of fluid conduits. The plurality of valves are configured to controllably allow flow from the at least one input port, through a selected set of the fluid conduits, to the at least one output port.
  • the one or more fluid conduits are selected prior to said implanting of the at least one reservoir and the plurality of fluid conduits.
  • the apparatus can be shipped from the manufacturer with the plurality of valves in a selected state corresponding to the predetermined flow rate of the treatment liquid.
  • the apparatus can be adjusted (e.g., by a surgeon or other health professional) prior to the surgical implantation procedure to modify the plurality of valves to be in a selected state corresponding to the predetermined flow rate of the treatment liquid.
  • the one or more fluid conduits are selected during said implanting.
  • the apparatus can be adjusted (e.g., by a surgeon or other health professional) during the surgical implantation procedure to modify the plurality of valves to be in a selected state corresponding to the predetermined flow rate of the treatment liquid.
  • the one or more fluid conduits are selected subsequently to said implanting of the at least one reservoir and the plurality of fluid conduits.
  • the apparatus can be adjusted remotely (e.g., by a health professional, clinician, or caregiver) by sending appropriate signals to an internal electromechanical mechanism (e.g., motor) of the apparatus.
  • the method 400 further comprises changing the flow rate of the treatment liquid to the recipient by changing the selected one or more fluid conduits that are in fluidic communication with the at least one reservoir subsequently to said implanting (e.g., by adjusting the apparatus remotely using an internal electromechanical mechanism (e.g., motor) of the apparatus.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
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Abstract

L'invention concerne un appareil qui comprend une pluralité de conduits et une pluralité de vannes en communication fluidique avec la pluralité de conduits. La pluralité de conduits est conçue pour recevoir un liquide provenant d'au moins un réservoir de liquide conçu pour être implanté sur ou à l'intérieur d'un receveur. Chaque conduit de la pluralité de conduits présente une résistance à l'écoulement correspondante au liquide. La pluralité de vannes est conçue pour permettre l'écoulement régulé du liquide à travers un ensemble sélectionné des conduits pour être administré de façon interne au receveur à un débit sélectionné.
PCT/IB2019/059891 2018-11-20 2019-11-18 Dispositif à taux d'administration de médicament sélectionnable WO2020104918A1 (fr)

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US17/265,071 US20210244878A1 (en) 2018-11-20 2019-11-18 Selectable drug delivery rate device

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US62/769,690 2018-11-20

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